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Compassionate Use of Gemtuzumab Ozogamicin (Mylotarg) for Treatment of Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML) or Acute Promyelocytic Leukemia (APL)


N/A
3 Months
N/A
Not Enrolling
Both
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Promyelocytic Leukemia (M3), Childhood Acute Promyelocytic Leukemia (M3), Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia

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Trial Information

Compassionate Use of Gemtuzumab Ozogamicin (Mylotarg) for Treatment of Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML) or Acute Promyelocytic Leukemia (APL)


PRIMARY OBJECTIVES:

I. To provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia
(APL), who have relapsed or who are refractory to standard treatments, with access to
gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative
therapy is available.

II. To carefully monitor safety and to report safety information from patients receiving
Mylotarg in this setting.

OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.

After completion of study treatment, patients are followed up every month for 1 year.


Inclusion Criteria:



- Diagnosis of relapsed or refractory AML and not candidate for standard consolidation
treatment after daunorubicin and cytosine arabinoside OR diagnosis of APL relapsed
after tretinoin (ATRA) and arsenic trioxide therapy or APL with persisting or rising
blasts, and no other comparable or satisfactory alternative therapy available
(including patients not eligible for, or who have access to, investigational
therapies via a clinical trial)

- Patients must have an initial diagnosis of AML, biphenotypic acute leukemia, or APL

- Patients must have cluster of differentiation (CD)33 positivity of > 30%

- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 / Karnofsky > 60%

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2 x institutional upper limit of normal

- It is deemed ethical to provide an experimental drug (e.g., Mylotarg) that is
associated with hepatotoxicity (veno-occlusive disease [VOD]) and myelosuppression

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to receiving Mylotarg
and for the duration of treatment; should a woman become pregnant or suspect she is
pregnant while receiving treatment with Mylotarg, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written Institutional Review
Board (IRB)-approved informed consent document

Exclusion Criteria:

- Patients may not currently be receiving any other investigational agents for leukemia

- Patients with known untreated hepatitis C

- Uncontrolled intercurrent illness including, but not limited to active liver disease,
or psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with Mylotarg

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible; appropriate studies will be undertaken in patients receiving
combination antiretroviral therapy when indicated

- Patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts:
recombinant humanized anti-CD33 monoclonal (hP67.6) antibody, calicheamicin
derivatives or other ingredients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Access to gemtuzumab ozogamicin

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Leslie Ellis

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CCCWFU# 99213

NCT ID:

NCT01869803

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Promyelocytic Leukemia (M3)
  • Childhood Acute Promyelocytic Leukemia (M3)
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Promyelocytic, Acute

Name

Location

Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082